Systems and methods to account for neck movement during nerve stimulation

• US 9,314,627 B2
• Filed: 04/23/2012
• Issued: 04/19/2016
• Est. Priority Date: 04/25/2011
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Arcot-Krishnamurthy, Shantha, Ruble, Stephen, Hamann, Jason J., Ordonez, Juan Gabriel Hincapie, Ternes, David J.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US13/453,279
• Publication Number:
  US 20120271382A1
• Time in Patent Office: 1,457 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Some embodiments provide a method, comprising performing a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein for each of a plurality of head positions, performing the neural stimulation test routine includes testing a plurality of electrode configurations. The method further comprises recording threshold data for each of the tested electrode configurations for the plurality of head positions, and recommending an electrode configuration based on the recorded threshold data.

Claims

1. A method, comprising:

performing a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein a patient'"'"'s head is moved into a plurality of positions including a plurality of selected head positions for threshold testing, and for each of a plurality of selected head positions, performing the neural stimulation test routine includes using a neural stimulator and electrodes to deliver neural stimulation to test a plurality of electrode configurations to provide threshold data, and collecting the threshold data;

recording the threshold data for each of the tested electrode configurations for the plurality of selected head positions; and

recommending an electrode configuration based on the recorded threshold data using an algorithm executed by a processor.

2. The method of claim 1, wherein performing the neural stimulation test routine includes using at least one intravascular electrode to transvascularly deliver neural stimulation to the neural target.

3. The method of claim 1, wherein performing the neural stimulation test routine includes using at least one electrode in a carotid sheath of the patient to stimulate the neural target.

4. The method of claim 1, wherein performing the neural stimulation test routine includes using at least one electrode lying next to the neural target.

5. The method of claim 1, wherein testing the plurality of electrode configurations includes testing a desired response threshold, the desired response threshold representing a threshold for obtaining a desired physiological response to neural stimulation.

6. The method of claim 5, wherein the neural target is a cervical vagus nerve and the desired response threshold is a laryngeal vibration threshold.

7. The method of claim 5, further comprising

determining a highest desired response threshold for each of the electrode configurations using recorded threshold data for each of the selected head positions,

wherein recommending the electrode configuration based on the recorded threshold data includes recommending an electrode configuration having a lowest value for the highest desired response thresholds.

8. The method of claim 7, wherein the threshold data includes a threshold current amplitude, the method further comprising recommending a stimulation current for the recommended electrode configuration, wherein the recommended stimulation current has an amplitude corresponding to the threshold current amplitude with a safety factor.

9. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes testing an undesired response threshold, the undesired response threshold representing a threshold for obtaining an undesired physiological response to neural stimulation.

10. The method of claim 9, wherein the neural target is a cervical vagus nerve and wherein testing an undesired response threshold to neural stimulation includes receiving patient-entered or clinician-entered feedback to provide the threshold data.

11. The method of claim 9, wherein the neural target is a cervical vagus nerve and the undesired resp onse threshold is a cough threshold.

12. The method of claim 9, further comprising determining a lowest undesired threshold for each electrode configuration using recorded threshold data for each head position, wherein recommending the electrode configuration based on the recorded threshold data includes recommending an electrode configuration having a highest value for the lowest undesired response thresholds.

13. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes testing both a desired response threshold and an undesired response threshold, the desired response threshold representing a threshold for obtaining a desired physiological response to the neural stimulation and the undesired response threshold representing a threshold for obtaining an undesired physiological response to the neural stimulation.

14. The method of claim 13, further comprising:

determining both a highest desired response threshold and a lowest undesired response threshold for each electrode configuration using recorded threshold data for each of the head positions;

determining a lowest value for the highest desired response thresholds; and

determining a highest value for the lowest undesired thresholds,

wherein recommending the electrode configuration includes recommending the electrode configuration as a function of both the lowest value for the highest desired resp onse thresholds and the highest value for the lowest undesired response thresholds.

15. The method of claim 14, wherein the threshold data is sensed using a pressure sensor, an accelerometer, a minute ventilation sensor, an impedance sensor, a sensor configured to detect an electrocardiogram (EKG), a sensor configured to detect an electromyogram (EMG), or a blood pressure sensor.

16. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes receiving p atient-entered or clinician-entered feedback to provide the threshold data.

17. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes using an implanted sensor or an external sensor to sense the threshold data.

18. A method, comprising:

performing a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein a patient'"'"'s head is moved into a plurality of positions including a plurality of selected head positions for threshold testing.and for each of a plurality of selected head positions, performing the neural stimulation test routine includes using a neural stimulator to deliver neural stimulation to test a plurality of electrode configurations to provide threshold data for a desired response threshold and collecting the threshold data, the desired response threshold representing a threshold for obtaining a desired physiological response to the neural stimulation;

recording the threshold data for each of the tested electrode configurations for the plurality of selected head positions; and

recommending an electrode configuration based on the recorded threshold data using an algorithm executed by a processor.

19. The method of claim 18, wherein testing the threshold for the plurality of tested electrode configurations includes testing an undesired response threshold, the undesired response threshold representing a threshold for obtaining an undesired physiological response to the neural stimulation.

20. The method of claim 18, wherein testing the threshold for the plurality of tested electrode configurations includes receiving patient-entered or clinician-entered feedback to provide the threshold data.

21. The method of claim 18, wherein testing the threshold for the plurality of tested electrode configurations includes using an implanted sensor or an external sensor to sense the threshold data.

22. The method of claim 21, wherein the threshold data is sensed using a pressure sensor, an accelerometer, a minute ventilation sensor, an impedance sensor, a sensor configured to detect an electrocardiogram (EKG), a sensor configured to detect an electromyogram (EM G), or a blood pressure sensor.

23. The method of claim 18, wherein the neural target is a cervical vagus nerve and the desired response threshold is a laryngeal vibration threshold.

24. The method of claim 23, further comprising:

determining a highest desired response threshold for each of the electrode configurations using recorded threshold data for each of the selected head positions,

wherein recommending the electrode configuration based on the recorded threshold data includes recommending an electrode configuration having a lowest value for the highest desired response thresholds.

25. The method of claim 24, wherein the threshold data includes a threshold current amplitude, the method further comprising recommending a stimulation current for the recommended electrode configuration, wherein the recommended stimulation current has an amplitude corresponding to the threshold current amplitude with a safety factor.